Greg Ball Email & Phone Number

Gaithersburg, Maryland, Us

• Created a Safety Statistics group embedded in the Global Vaccine Safety organizationo Provided strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencieso Provided scientific input for the analysis and reporting of clinical and postmarketing safety data and ensured appropriate interpretation of safety deliverables in collaboration with Clinical Developmento Provided oversight on cross-functional development of output specifications to address pre-planned safety analyses and ad hoc requestso Guided development and implementation of project-specific database-related activities in collaboration with Biostatistics and other stakeholderso Ensured accuracy and internal consistency of reports and publications, including tables, listings, and figures• Co-leading the PhUSE Safety Analytics working group (with Mary Nilsson)o Envisioned and created the Safety Graphics Consortium, a network of existing working groups/project teams focused on safety graphics for clinical trialso Preparing the ecosystem for operationalizing the FDA Medical Queries and Standard Safety Tables and Figureso Panelist at the Duke Margolis-FDA Workshop: Advancing Premarket Safety Analytics for stakeholder perspectives exploring premarket AE groupingo Organizing community forums with DIA-ASA Interdisciplinary Safety Evaluation (DAISE) working group: Aggregate Safety Assessment Planning (ASAP) and Interactive Safety Graphics (ISG) project teams and with PhUSE Data Visualization and Opensource Technology working group: Interactive Data Visualizations for Regulatory Decisionmaking project teamo Created the PhUSE AE Groupings in Safety (AEGiS) project team

Rahway, New Jersey, Us

• Co-led a company initiative between Clinical Safety Statistics (CSS) and Clinical Safety and Risk Management (CSRM) to develop a Standard Operating Procedure (SOP) for routine periodic review and evaluation of accumulating clinical trial safety data for characterizing the safety profile and assessing new safety issues for products in development• Co-led the Biostatistics and Research Decision Sciences (BARDS) Early/Late-Stage Statistics Technical Issues Committee (ELSTIC) Safety Analysis working group to create and align guidance for study-level and program-level safety evaluation • Co-mentored (with CSRM) and managed a postdoc to develop innovative, interdisciplinary methodologies, procedures, and tools to support the clinical safety signaling process• Main driver of a cross-disciplinary company-wide initiative to develop an innovative new safety assessment process to improve the overall quality of safety monitoring and reporting and to comply with requirements for IND safety reports based on data in the aggregate o Co-led the Blinded Ongoing Aggregate Safety Evaluation (Blinded-OASE) workstream o Orchestrated the consultation with Janet Wittes; coordinated team effort and knowledge synthesis for 2 face-to-face meetings, 2 WebEx meetings and 2 updates to our sponsors o Spearheaded the effort to create 3 execution resources for the comprehensive new Aggregate Safety Assessment Planning (ASAP) process and Blinded and Unblinded Ongoing Aggregate Safety Evaluation (Blinded and Unblinded-OASE) o Pioneered the ASAP/OASE process in late-stage and postmarketing programs• Created, developed, and implemented a procedure, with a collaborative process and a quantitative framework, for review of aggregate blinded clinical trial data to support safety signal detection and risk management activities (Ball & Schnell, 2016; Schnell & Ball, 2016)

North Chicago, Illinois, Us

• Designed and developed a new Bayesian methodology for safety monitoring with blinded data and led the cross-disciplinary effort to evaluate it in an ongoing study (Ball, 2011; Wen, Ball & Day, 2015) o Consulted with Brad Carlin, Dave DeMets, Joseph Ibrahim, LJ Wei, and Patrick Schnell• Led the scientific evaluation of aggregate safety data for global regulatory approval of a 3-drug combination of direct-acting antivirals for the treatment of HCV o Developed and executed a cumulative meta-analytic approach for aggregate safety evaluation to respond to requests from regulatory authorities o Explored the association between concomitant estrogen use and ALT elevations; convincingly presented statistical analyses and logical arguments to regulatory authorities, which resulted in the contraindication of only ethinyl estradiol estrogens (primarily oral contraceptives) rather than all estrogens (including most hormone replacement therapies) in this mostly elderly population• Provided statistical leadership for clinical development strategy in Acute Kidney Injury (AKI), for the design, analysis and reporting of clinical trials and for interacting with regulatory authorities o Consulted with Tom Fleming, Gary Koch & LJ Wei and collaborated with study team members to develop a composite registration endpoint for prevention of AKI

• Developed a Bayesian method for safety monitoring with blinded data (Ball, 2008 and 2011)• Participated on a project team to acquire a partner for further development of a compound• Collaborated on project teams to quickly respond to evolving project needs and to design and carry out useful and informative analyses o Managed programmers and statisticians to ensure proper analyses were carried out and delivered on time o Provided sample size calculations, reviewed protocols, wrote the statistical methods section, and developed randomization schedules, statistical analysis plans and classification specifications o Organized and led format, data and results review meetings, participated in safety review meetings, wrote statistical reports, reviewed study reports, and contributed on presentations and manuscripts• Helped colleagues with non-standard statistical analyses o Simulation for the effect of stratified randomization on study power o Cox regression with a time dependent covariate o Adjusted correlation analyses

Durham, North Carolina, Us

• Interacted with clients regarding statistical analysis issues, carried out exploratory analyses and prepared presentations• Created statistical analysis plans and table shells and wrote the statistical methods section for study protocols• Reviewed statistical output, research proposals, and manuscripts and helped colleagues with non-standard statistical requests

• Participated on study teams to design and carry out analyses of clinical trial data and provided statistical consulting o Managed the statistical activities of projects and guided the efforts of statistical programmers o Created statistical analysis plans and table shells and wrote the statistical methods section for study protocols o Reviewed accuracy, interpretation, and presentation of statistical output and composed statistical reports and presentations• Implemented a retention-of-effect analysis in a non-inferiority trial• Served as project manager for 2 studies• Designed and implemented a workbook for generating statistical bids• Constructed a statistical analysis plan template• Helped revise the standard operating procedure for statistical analysis plans• Helped develop a quality control plan for producing statistical output• Made presentations about mixed models

• Assisted in the development and implementation of a nursing research program• Provided statistical support for performance improvement initiatives

Houston, Tx, Us

• Collaborated with physicians to conduct oncology research and publish scientific paperso Determined early stopping rules with continuous Bayesian monitoring designso Studied the functional form of continuous variables with martingale residual analysiso Classified patients according to their survival with recursive partitioningo Used mixed models to make comparisons across timeo Adjusted for covariates using Cox proportional hazards and generalized linear modelso Made estimates and plots of survival data using Kaplan-Meier methodso Used parametric and non-parametric methods to compare treatment groups

West Lafayette, In, Us

• Taught graduate level probability and statistics courses to MBA and education students• Analyzed the effect of feed treatments and additives on pork belly firmness• Studied the effect of a resource seminar on student success in 1st year biology• Investigated the effect of obesity on the risk of bladder cancer in household dogs• Co-president of the statistic’s graduate student organization

• Created math labs with graphing calculators to reinforce critical concepts• Implemented school projects with an architect to apply knowledge to real-world problems• Hosted a Japanese teacher and a Swiss student to promote cultural diversity

Washington, Dc, Us

• Developed leadership, management and communication skills• Assistant department head of 90 men

Doctor Of Philosophy (Phd), Biostatistics

Master Of Science (Ms), Statistics

Master Of Arts (Ma), Mathematics Teacher Education

Bachelor Of Arts (Ba), Economics